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Study of ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies

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ClinicalTrials.gov Identifier: NCT03768505
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
MEI Pharma, Inc.

Brief Summary:
This is the study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy

Condition or disease Intervention/treatment Phase
Follicular Lymphoma (FL) Drug: ME-401 Phase 2

Detailed Description:
This is a global, multicenter, randomized, double-blind, placebo-controlled, 2 arm, Phase 2 study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. The study will evaluate the efficacy and safety of ME-401 administered using two different schedules: daily continuously or daily continuously for 2 cycles then daily for the first 7 days of each subsequent cycle. Approximately 165 subjects will be randomized into the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Group A, Continuous schedule
ME-401 administered daily continuously, in a capsule, taken orally
Drug: ME-401
ME-401

Experimental: Group B, Intermittent schedule
ME-401 administered daily continuously for 2 cycles then daily for the first 7 days of each subsequent cycle, in a capsule, taken orally
Drug: ME-401
ME-401




Primary Outcome Measures :
  1. Objective response rate (ORR) of ME-401 in relapsed FL, defined as the best response rating of complete response (CR) or partial response (PR) [ Time Frame: 2 years ]
    ORR is measured according to the Lugano Response Criteria (Cheson 2014), as determined by an Independent Response Review Committee (IRRC)

  2. Tolerability of ME-401, defined as the rate of AEs requiring modified dosing schedule or study drug discontinuation (AERDM) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Efficacy of ME-401, as assessed by an Independent Response Review Committee (IRRC): Duration of response (DOR) among subjects with an objective response [ Time Frame: 2 years ]
  2. Efficacy of ME-401, as assessed by an Independent Response Review Committee (IRRC): Complete response (CR) rate [ Time Frame: 2 years ]
  3. Efficacy of ME-401, as assessed by an Independent Response Review Committee (IRRC): Progression-free survival (PFS) [ Time Frame: 2 years ]
  4. Efficacy of ME-401, as assessed by the Investigator: Objective response rate (ORR) [ Time Frame: 2 years ]
  5. Efficacy of ME-401, as assessed by the Investigator: Duration of response (DOR) among subjects with an objective response [ Time Frame: 2 years ]
  6. Efficacy of ME-401, as assessed by the Investigator: Complete response (CR) rate [ Time Frame: 2 years ]
  7. Efficacy of ME-401, as assessed by the Investigator: Progression-free survival (PFS) [ Time Frame: 2 years ]
  8. Overall survival (OS) [ Time Frame: 2 year ]
    Overall survival

  9. Safety profile of ME-401: Overall incidence of AEs [ Time Frame: 2 years ]
  10. Safety profile of ME-401: Time to occurrence of AERDM [ Time Frame: 2 years ]
  11. PK of ME-401 [ Time Frame: 6 months ]
    To evaluate ME-401 PK by obtaining plasma samples



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of follicular lymphoma (FL) as defined in the World Health Organization (WHO) classification scheme, limited to Grade 1, 2, or 3a
  2. Progression of disease after at least 2 prior systemic therapies for FL
  3. No prior therapy with PI3Kδ inhibitors
  4. No disease progression on prior therapy with Bruton tyrosine kinase (BTK) inhibitors
  5. At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
  6. Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
  7. QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
  8. Left ventricular ejection fraction (LVEF) ≥ than institutional lower limit of normal as measured by echocardiogram

Exclusion Criteria:

  1. Known active histological transformation from FL to an aggressive lymphoma
  2. Any uncontrolled clinically significant illness
  3. Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody plus have a positive hepatitis B
  4. Ongoing or history of drug-induced pneumonitis
  5. History of clinically significant cardiovascular abnormalities
  6. History of clinically significant GI conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768505


Contacts
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Contact: MEI Pharma MEI Pharma 858-369-7100 Patients@meipharma.com

Locations
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United States, California
Pacific Cancer Medical Center, Inc. Recruiting
Anaheim, California, United States, 92801
The Oncology Institute of Hope and Innovation Recruiting
Downey, California, United States, 90241
United States, Indiana
Investigative Clinical Research of Indiana LLC Not yet recruiting
Indianapolis, Indiana, United States, 46260
United States, Texas
Renovatio Clinical Recruiting
Houston, Texas, United States, 77056
United States, Washington
Medical Oncology Associates PS Recruiting
Spokane, Washington, United States, 99208
Sponsors and Collaborators
MEI Pharma, Inc.

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Responsible Party: MEI Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03768505     History of Changes
Other Study ID Numbers: ME-401-003
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin